According to statistics published by the National Institutes of Health, over ten million Americans ha any one of several types of urinary incontinence. More fifty-percent are women and all age groups are affected.
The complete urinary incontinence of the neurogenic bladder is the worse type for there is no satisfactory surgical procedure to control the urine leakage. An implantable mechanical sphincter-like mechanism with hydraulic control has been developed in recent years. These operations long and difficult and complications sometimes do occur. The whole procedure is very expensive and can be done by a select few urologic surgeons. None of the urinary diversion operations are satisfactory. There are over fifteen the cause of the neurogenic bladder; e.g., spina bifida, mechanical trauma to the spinal cord, viral and bacterial disease of cord, Diabetic neuropathy, tumors, Multiple Sclerosis, Parkinsons Disease, pelvic tumors after resection or radiation general deteriorization with advancing age.
The most common type of female incontinence called "Stress Incontinence". Three-fourths of all female patients have this type of incontinence. The main cause is of weakness of stretched or sagging structural tissue in the the pelvis, the bladder, vagina, and/or muscles of the pelvic floor. The angle at the bladder-uretheral junction should be 90.degree.. In prolapsed bladder this angle is lost, then the bladder urinary control mechanism functions poorly. The bladder is capable of holding the urine in if no stress is applied intra-abdominally. Coughing, sneezing, carrying a heavy object will increase the intra-abdominal pressure which in turn transmits the pressure to the urinary bladder. The sphincters cannot hold this extra pressure and some urine is lost. Operations that correct the anatomical defects are generally successful. Recurrence is a problem after a few years and repeat procedures are done. The problems in the female are complex. In the male patients, external catheter mechanisms are an effective means of urinary collection, in the female, no feasible collection receptacle has been devised.
The following prior art is known to Applicant:
The following patents disclose various catamenial devices and are believed to be of only general interest concerning the teachings of the present invention:
U.S. Pat. Nos. 679,478 to Lang, 1,241,652 to Norquist, 1,996,242 to Hagedorn, 3,157,180 to Bakunin, 3,298,369 to Pirie.
U.S. Pat. No. 2,649,086 to Sluijter discloses a ring-like apparatus designed to be inserted within the vagina and including a thickened portion intended to be pressed against the urethra. The present invention differs from the teachings of Sluijter as including a U-shaped appliance having an inflatable bulb associated therewith.
U.S. Pat. No. 2,638,093 to Kulick, Applicant herein, discloses a device designed to be inserted into the vagina and including an inflatable bulb designed to project, when inflated, through an opening therein and to press against the urethra. While this invention has been effective in curing urinary incontinence, the one slight drawback of this invention rests in the ability of the device to be moved away from the front of the vagina adjacent the urethra as the balloon 25 thereof is inflated, due to the ability of the vagina to stretch, thus reducing the pressure which may be exerted against the urethra. The present invention eliminates this problem by providing a U-shaped prosthesis having one leg of the "U" inserted within the vagina and having an inflatable balloon attached thereto, and with the other leg of the "U" resting against the mons pubis to prevent movements of the first-mentioned leg away from adjacency to the urethra during inflation of the balloon. Thus, a measured amount of air injected into the balloon will exert a rather constant pressure.
U.S. Pat. No. 3,419,008 to Plishner is cited as an example of a surgically implanted valve clamp designed to be mounted in surrounding relation to the urethra and to be controlled by external control. Since the present invention does not require surgical intervention and includes many features nowhere taught or suggested by Plishner, Plishner is believed to be of only general background interest.
U.S. Pat. No. 3,334,184 to Habib discloses a pubo-vaginal incontinence device including two legs, with one leg adapted to be inserted within the vagina and including a curved portion designed to press against the urethra. The other leg is designed to engage the area of the symphysis pubis. The present invention differs from the teachings of Habib as including a U-shaped prosthesis wherein the leg which is inserted within the vagina is specifically sized and configured to snugly fit therein and includes the further provision of an inflatable balloon. Such structure is nowhere taught or suggested by Habib.
U.S. Pat. No. 3,705,575 to Edwards discloses an incontinence device for female use including one leg designed to be inserted within the vagina to exert pressure against the urethra and another leg designed to engage the mons pubis. Edwards further contemplates the application of intermittent electrical current impulses via the device. Again, the present invention differs from the teachings of Edwards as including one leg specifically sized and configured to snugly fit within the vagina and having an inflatable balloon incorporated therewith. These aspects are nowhere taught or suggested by Edwards.
U.S. Pat. No. 3,709,215 to Richmond discloses an adjustable device designed with one leg insertable into the vagina and another leg bearing against the mons pubis. The Richmond device is specifically designed such that the leg inserted within the vagina is extremely thin, allowing retraction of the vagina for surgical purposes. This is completely opposite to the teachings of the present invention, wherein the leg which is inserted into the vagina is sized and configured to snugly fit within the vagina and includes an inflatable balloon. As such, the present invention is believed distinct from the teachings of Richmond.
U.S. Pat. No. 4,290,420 to Manetta discloses a stress incontinence diagnostic and treatment device including a V-shaped configuration having one leg insertable into the bottom portion of the vagina and the other leg extending forward over the mons pubis and held there by a belt 20. This is different from the teachings of the present invention, wherein one leg is inserted into the vagina and is sized and configured to be snugly received therein and includes an inflatable balloon. Additionally, the present invention is specifically designed to not require any belt to hold it in place.